Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-04 @ 12:44 PM
Study NCT ID:
NCT03909633
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2018-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2018-10-21', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in patient's cognitive dysfunction evaluated by WCST", 'timeFrame': '4 months', 'description': 'The Wisconsin Card Sorting Test (WCST) is a neuropsychological test of "set-shifting",.A number of stimulus cards are presented to the participant. The participant is told to match the cards, but not how to match; however, he or she is told whether a particular match is right or wrong. The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors'}, {'measure': "Change in patient's cognitive dysfunction evaluated by DST", 'timeFrame': '4 months', 'description': "DST(Digit Span Test.),It is used to measure working memory's number storage capacity. Participants see or hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sequence in normal or reverse order.Digit-span tasks are the most commonly used test for memory span, partially because performance on a digit-span task cannot be affected by factors such as semantics, frequency of appearance in daily life, complexity, etc."}, {'measure': "Change in patient's cognitive dysfunction evaluated by DSST", 'timeFrame': '4 months', 'description': 'DSST(Digit Symbol Test).,The participants need to write the number referred to each symbol in 90 seconds.Number of hits are registered. The test measures short-term memory, visualspatial skills and attention.'}, {'measure': "Change in patient's cognitive dysfunction evaluated by MoCA", 'timeFrame': '4 months', 'description': 'MoCA （Montreal Cognitive Assessment）, The visual spatial executive ability, naming,memory, attention, language fluency, abstract,thinking, delayed memory and directional force are included in the test, a total of 30 points. The subjects whose have less than 12-year of education were added 1 point in the testing result, with correction of bias in the degree of culture. The patients whose get higher scores indicate that the cognitive function is better, 26 points as normal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Function']}, 'descriptionModule': {'briefSummary': 'The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved', 'detailedDescription': 'The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved.The investigators assess cognitive function through a series of tests for 4 times( within 3 days before the endoscopy ,2 hours after the endoscopy finished,1 week after the endoscopy,3 months after the endoscopy),including WCST、DSST、DST、HADS、MoCA,through self - contrast,the investigators will conclude whether intravenous anesthesia has bad impact on cognitive function or not .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients will undergoing endoscopy check for all kinds of reasons', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* voluntary to participate in\n* Vital signs are stable\n* no drug or alcohol abuse\n* no mental illness\n* no severe central system diseases such as brain infarction\n* between 18 and 80\n* no liver or kidney dysfunction\n* will perform endoscopy for various reasons\n\nExclusion Criteria:\n\n* illiteracy\n* color blindness\n* can't write or refused to sign informed consent\n* unable to follow up regularly or cooperate with the examination\n* drug or alcohol abuse\n* hearing or visual serious impairment\n* has severe central nervous system diseases such as shoke ,neurosyphilis\n* uncontrolled high blood pressure or hyperglycemia\n* neurosyphilis\n* history of craniotomy for various reasons\n* liver and kidney dysfunction\n* non-digestive tumors\n* history of intravenous or general anesthesia for other causes in the last 3 months"}, 'identificationModule': {'nctId': 'NCT03909633', 'briefTitle': 'Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy', 'orgStudyIdInfo': {'id': 'IR2018001085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A: anesthesia group', 'description': 'Patients accepting endoscopy check under anesthesia will be included in this group as group A,will doing a series of tests', 'interventionNames': ['Behavioral: a series of tests']}, {'label': 'B:Non-anesthesia group', 'description': 'patients undergoing endoscopy check without anesthesia will be included in this group as controls voluntarily,namely group B,will doing a series of tests', 'interventionNames': ['Behavioral: a series of tests']}], 'interventions': [{'name': 'a series of tests', 'type': 'BEHAVIORAL', 'description': 'all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS', 'armGroupLabels': ['A: anesthesia group', 'B:Non-anesthesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cai J Ting', 'role': 'CONTACT', 'email': '1173920428@qq.com', 'phone': '15267019902', 'phoneExt': '13805716757'}, {'name': 'Chen Xiao', 'role': 'CONTACT', 'email': '1173920428@qq.com', 'phone': '15267019902', 'phoneExt': '13805716757'}], 'facility': 'Cai Jian Ting', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wang J AN', 'role': 'CONTACT', 'email': 'HREC2013@126.com', 'phone': '057187783759', 'phoneExt': '057187783759'}, {'name': 'Cai J Ting', 'role': 'CONTACT', 'email': '1173920428@qq.com', 'phone': '15267019902'}], 'overallOfficials': [{'name': 'Cai J Ting', 'role': 'STUDY_CHAIR', 'affiliation': 'Second affiliated hospital of school of medicine, zhejiang university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'to protect Patient privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}